Patenting Life? - An Introduction to the Issues
Once upon a time we knew that animals were products of nature. We used them and “owned” them, but it was different from owning a pair of shoes. Animals could get up and walk away; shoes couldn’t. And unlike patent leather, you couldn’t patent a cow. Patents are about inventions, and since when had human beings invented an animal?
Since 1984, if you believe Harvard University and the US Patent Office. For that was when Harvard applied for a patent on a genetically modified mouse, which was granted 4 years later, causing a big bang of controversy which soon reached the shores of Europe and whose ripples are still very much in evidence. For this was the first time it was officially decreed that an animal could indeed be classed as an invention. Moreover, it was a mouse specifically engineered to have an increased probability of suffering malignant tumours - for use as a “model” for studying human cancers and carcinogens.
Controversy in Europe
The combination of these two factors has raised human hackles far and wide. It generates surprisingly heated arguments wherever the issue is debated. The question of patenting “animate matter” has given long term headaches to the European Patent Office in Munich, and in March 1995 it led to the first ever rejection by the European Parliament of a European Commission directive. A new draft EC Directive on patenting is currently being discussed in the early committee stages of the European Parliament, and is again the subject of deep seated controversy between industry proponents and many diverse groups which include church groups, NGO’s, environmental and animal welfare organisations, and also many doctors, farmers and ethicists.
Biotechnological Inventions - Products of Nature or Products of Industry?
You cannot patent a mere discovery. It must have a non-obvious “inventive step”, and some specified practical application. Patent law was framed in an industrial context, and typically applied to objects, chemicals, designs and processes. Agriculture was seen as lying outside this realm. You could patent a mouse trap, but not a mouse. But, with the rise of biotechnology, a shift has occurred, partly in technical sense, and partly in our perceptions.
Once it became possible to alter the genetic makeup of living things, researchers could genuinely claim an “inventive step” in the organism itself. And since such research is expensive and easily copied, organisations wanted to patenting genetically modified organisms to protect their valuable investment. The key case concerned a micro-organism, perhaps only a small step from patenting biochemical products. It went right up to the US Supreme Court, who in 1980 ruled that “anything under the sun that is made by man” was patentable subject matter, which turned it into the giant leap which has set the trend ever since. But it was not until its implications began to extend from micro-organisms to warm and furry animals that the fundamental question dawned on people generally : were they right?
Oncomice, transgenic sheep, or whatever: should we be patenting our fellow creatures at all? Isn’t this violating something rather basic in our attitudes to nature, implying they are nothing more than machines for our use? We say we “own” animals, but what does this really mean? They have their own lives and freedom which we are surely to respect - simply as parts of nature alongside us, and, from a Christian perspective, as God’s creatures each of inherent worth. For many, the heart of the problem is that to patent an animal includes it in the same category as mere mechanical objects. Is that symbolic association sending ourselves and our society entirely the wrong kind of signal? Patent expert Stephen Crespi suggests that living things are now regarded as “products of manufacture” and agriculture to be a kind of industry. If this is true, is this a shift in perception we should be counteracting?
Patenting the Human Genome - Losing Investments or Losing our Humanity?
We are not just talking about animals and plants. Sections of the human genome are being identified by the thousand. Should these be patentable, if you could prove they weren’t just “discoveries”? Many US researchers with an eye to the main chance thought “yes”. The subsequent transatlantic scramble to grab the richest pickings from the Human Genome Project has demonstrated that once one player starts protecting, it puts everyone else under pressure to follow suit. Dubious and torturous arguments are posed to try to prove that a copied human gene is not a discovery. But these obscure the basic question - is the patenting of sections of the human genome simply an abuse of human dignity, under the guise of commercial enterprise?
Alternatively, is the controversy a storm in a tea cup, as much of the biotechnology industry maintains, a storm threatening its competitve prospects and the very fibre of its work? If they cannot patent, it is claimed, then no one will invest the large sums of capial needed for genetic research, or it will all simply be kept secret. Advances in science, medicine and agriculture will be curtailed, information will not be shared. Avoidable suffering will go unallieviated and economic opportunities lost to other nations who aren’t so fussy about non-issues. Against these powerful arguments, who would stand in the way? Well ... quite a lot of people, it would seem.
If animals or our own genes are products of nature then we cannot claim invention. If they are nothing more than products of industry then I believe we are losing something of our humanity by putting then in the same box as widgets. If they are both, however, then perhaps we need a new system of intellectual property involving living material, instead of shoring up a patenting system which was manifestly not designed for such cases. Much depends on what we need to patent. There is a good case for a pharmaceutical company gaining a patent on, say, the use a section of the human genome to produce a particular therapeutic drug. But it is a very different matter if the same company claims a patent on the sequence itself, for any use whatsoever, just by virtue of having invested a lot of money in isolating it and having identified its function in the body. To many people, that is one step too far, and is claiming more than is justified, for what is still only a discovery, not a true invention. It is also feared it could actually hamper research and delay vital discoveries, by putting off other companies from investing in other potential therapeutic uses of the same gene.
There is also the moral dimension. Many people would also say that knowledge of a genetic sequence itself is part of the global commons and should be for all to benefit from. To patent parts of the human genome as such, even in the form of “copy genes”, would be ethically unacceptable to many in Europe. In response it is argued that patenting is the legal assessment of patent claims, and should not be confused with ethics. But patenting is already an ethical activity, firstly in that it expresses a certain set of ethical values of our society; it is a response to a question of justice, to prevent unfair exploitation of inventions. Secondly a clause excluding inventions “contrary to public order and decency” is part of most European patent legislation - an extreme case of something like a letter bomb would be excluded as immoral. But now we have brought cancerous mice and human genetic material in the potential frame of intellectual property, ethics has moved to a much more central position, where it sits uncomfortably with the patenting profession. They do not like the role of ethical adjudicator to be thrust upon them by society. And they have a point. Patenting is probably the wrong place for society to be deciding once and for all the morality of, say, the oncomouse. But this only points to a serious anomaly in the way we assess biotechnology.
The Need for a Public Forum to Debate the Ethics of Biotechnological Inventions
A patent is a negative right. It does not give you the right to use your invention, it simply prevents someone else from doing so, without your permission. The upshot of this is illustrated by the case of a mouse modified for experiments into baldness. It was refused a patent because its purpose was trivial compared with the suffering of the animal. But refusing the patent did not mean the company had to stop making it; it meant that anyone could make it! Surely, if a patent is refused on ethical grounds, it must then automatically become illegal to produce the thing. Yet there is apparently no legal provision that makes this so. If this would put too much onus on remote patent lawyers in Munich, then society as a whole should have a way to assess the ethical acceptability of a biotechnological invention, as an explicit precondition of a patent being granted. Sadly, this aspect was not properly addressed in the European Commission’s new Patenting Directive, and is a major shortcoming in the proposed legisation.
And that raises the last question. Part of the problem is that patenting is often the first time members of the public have any knowledge of biotechnological inventions, or effective access to an appeals procedure. The focus is in the wrong place. What is needed is a statutory national ethical commission, where inventions are made public, and given interim intellectual property protection while opportunity is given for the public to lodge objections (or voice support) and to appeal. If something is not done to grant such a public debate, the controversy over patenting living organisms will continue without any hope of resolution, and, in the long run, the bioindustry risks losing part of its public for the wrong reasons.